Bioequivalence and Bioavailability Forum

Dear Skar!

❝ Dear Sir,

    ▲ Not interested in ladies’ opinions‽

❝ The intra-subject CV is due to drug and formulation.

Not quite. You should also consider

• design issues (number and location of sampling time points, single dose vs. steady state),
  
• clinical setting (food, posture, physical activity), and
  
• analytical variability (mainly stability and to a lesser degree the method itself).

❝ So, is it appropriate to use CV-intra from literature of other’s product (others’ formulation) for sample size calculation?

Yes, but try to judge the credibility of the study. Add a safety margin. Using the plain number ‘as is’ I would consider careless.

Don’t forget your previous thread and today’s quote:

Statistics are no substitute for judgment. Henry Clay